The Opportunity

In this role, you will review protocols and reports, resolve anomalies in collaboration with cross-functional teams, and update SOPs to maintain alignment with the Quality Management System (QMS). With responsibilities spanning compliance to FDA QSR, ISO 13485, and ISO 14971, you'll play a critical part in upholding quality standards while meeting project timelines.

You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers. As part of the team, you will be in a Company that aims more than to become one of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of "making cancer a curable disease by detecting it earlier".

Why Now?

This is an exciting time to be at Universal DX. We are growing rapidly and starting our US operations by building up our team, starting our lab and business operations, and establishing strategic partnerships. We are looking for passionate changemakers to be a part of our journey in this expansive time for us.

How you'll contribute

• Reviews software or assay protocols and reports to ensure all changes are verified, and assay or software system is adequately validated in accordance with design controls and Quality System
• Proactively communicates variances and anomalies identified during the review process to Quality Management.
• Resolve minor protocol variances through collaboration with proper SMEs to ensure compliance and resolution.
• Collaborate cross-functionally with Assay and Software teams to resolve anomalies identified during the execution of the design and development deliverables.
• Identifies and updates SOP and Forms to ensure continuous compliance to the QMS and regulatory requirements.
• Must align to project timelines and complete review and approvals on time.
• Assists in the development and maintenance of departmental operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines (ISO 13485, ISO 14971), including 21 CFR Part 11
• Know & follow policies & procedures related to work activities performed in area of responsibility.
• Works independently with objectives given by QA Management
• Plans and coordinates own work according to higher-level project schedules.
• Completes quality tasks in accordance with current Quality System Requirements.
• Follow all functions and responsibilities associated to this position that are described in UDX documents.

What you'll bring

• Bachelor's degree in Life Sciences or Engineering or a related field.
• More than 5 years of experiences in a Quality Role, OR an equivalent combination of education,
training, and/or experience.
• More than 3 years of experience working with FDA approved, OR an equivalent combination of education
training, and/or experience.
• Single site PMA experience preferred.
• Working knowledge interpreting and implementing 21CFR820, ISO 13485, ISO 14971 and CLIA regulations.
• Exceptional communication skills in English, both spoken and written.

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